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A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

Status
Completed
Phase
I
Principal Investigator(s)
Katherine Bunge, Sharon Hillier
Objective

This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations.

Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Arms and Assigned Interventions
Description
1% vaginally applied tenofovir gel administered for 7 daily doses
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
HEC placebo vaginal gel administered for 7 daily doses
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Description
Tenofovir Film 10mg inserted vaginally, administered for 7 daily doses
Mode of Delivery
Film
Products
tenofovir
ARMs
Experimental
Description
Tenofovir Gel 40 mg inserted vaginally, administered for 7 daily doses
Mode of Delivery
Film
Products
tenofovir
ARMs
Experimental
Description
Placebo Film inserted vaginally, administered for 7 daily doses
Mode of Delivery
Film
ARMs
Placebo Comparator
Trial Sponsors
CONRAD
November 2013
January 2015
Enrollment
78
18
Years
45
Years
Population
Women
Sites

Magee Women's Hospital of UPMC

Pittsburgh
United States of America